Full Press Release Details
Medical Received Confirmation for the Commencement of Its CE Mark Approval Process During the First Half of 2024
Company's designated Notified Body confirmed dates for conducting audits for ISO 13485 certification to ensure Microbot complies
with the QMS requirements of the EU MDR
Company expects that the full CE Mark approval process of obtaining clearance of sales in the European Union for the LIBERTY
Robotic Surgical System, will be carried out in parallel with the FDA regulatory process
Mass., October 24, 2023 - Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY Robotic
Surgical System, today announces it has received confirmation for the commencement of the process to support its future CE Mark approval,
and to ultimately allow the Company to market the LIBERTY Robotic Surgical System in Europe as well as other regions
who accept the CE Mark.
to the confirmation, the Company will commence audits for ISO 13485 certification to ensure its compliance with the Quality Management
System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745), during the first half of 2024. The Company had previously
taken the first step to advance its European program by engaging with a leading Notified Body, who recently confirmed dates for conducting
the required audits.
audits for Microbot's ISO 13485 certification will incorporate an off-site audit that includes a review of the Company's
quality system and the LIBERTY Robotic Surgical System Technical File, followed by an on-site audit at the Company's
are confident that we have taken the right measures to successfully complete these audits, which will serve as the first step in our
commercial approval process for Europe as well as other regions across the globe which allow commercialization under the CE Mark,"
said Noa Ofer, Sr. Director QA/RA. "We intend that this process will be conducted in parallel with our FDA approval efforts, to
allow us to capture as many markets across the globe as we prepare for future commercialization."
Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies,
with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within
LIBERTY Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating
the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company
believes the LIBERTY Robotic Surgical System's remote operation has the potential to be the first system to democratize endovascular
interventional procedures.
information about Microbot Medical is available at http://www.microbotmedical.com.
to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities
for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or
prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that
contain words such as "will," "believes," "plans," "anticipates," "expects"
and "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and
uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of potential
products, including LIBERTY, the outcome of its studies to evaluate LIBERTY, whether the Company's core business focus program
and cost reduction plan are sufficient to enable the Company to continue to focus on its LIBERTY technology while it stabilizes its financial
condition and seeks additional working capital, any failure or inability to recruit physicians and clinicians to serve as primary investigators
to conduct regulatory studies which could adversely affect or delay such studies, uncertainty in the results of pre-clinical and clinical
trials or regulatory pathways and regulatory approvals, disruptions resulting from new and ongoing hostilities between Israel and the
Palestinians, such as employees of Microbot and its vendors and business partners being called to active military duty, any lingering
uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property
rights. Additional information on risks facing Microbot Medical can be found under the heading "Risk Factors" in Microbot
Medical's periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC's web
site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required